Sr CRA
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Key skills for this role
About the Role
**About The Job** Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Proc
Key Skills for This Role
Full Job Posting
About The Job
Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
What You'll Do
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV])
- and complete site visit deliverables with quality and within given timelines in Monitoring Plan while
- adhering to all applicable regulatory requirements, SOPs and ICH GCP
- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings; may include presentations
- Create and implement subject enrollment strategies for assigned study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
- Participate in the development of CRFs and other study related documents (subject worksheets,
- Monitoring Plan, etc.)
- Perform translation, customization, and review of Patient Information sheet and Informed Consent,
- protocol synopsis and other study applicable documents as per required procedures
- Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
- Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate
- Liaise with Clinical Data Management for data cleaning activities
- Serve as mentor / trainer for CRAs; may include conducting training/assessment visitsWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or
- revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. Provide regular updates to Sponsor/ Client
- Function in the role of Lead CRA for assigned project(s)
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an
@ctifacts.com
email address to guide you through our interview process.
Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- + We will never communicate with you via Microsoft Teams or text message.
- + We will never ask for your bank account information at any point during the recruitment process.
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